Medicine
Hemofil M kit
Hemofil M kit is a prescription medicine containing Antihemophilic factor human, marketed by Takeda Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
HEMOFIL M can be stored at 2°C to 8°C (36°F to 46°F) or at room temperature…
Key facts
- Active ingredient (INN)
- Antihemophilic factor human
- Brand
- Hemofil M
- Dosage form
- Kit
- Packs
- 1 kit and 1 more
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- HEMOFIL M can be stored at 2°C to 8°C (36°F to 46°F) or at room temperature, not to exceed 30°C (86°F), until expiration date noted on the package. Do not freeze.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 February 1988
- Identifiers
- RxCUI 1718962, 1718965DailyMed set ID b8953ff7-3bba-4a0b-a486-f26fb81f05d9NDC 0944-3940, 0944-3944, 0944-3946 +1Application BLA101448
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 kit in 1 carton * 10 mL in 1 bottle * 10 mL in 1 vial, glass | 0944-3940-02 | Takeda Pharmaceuticals | 23 February 1988 |
| 1 kit in 1 carton * 10 mL in 1 bottle * 10 mL in 1 vial, glass | 0944-3942-02 | Takeda Pharmaceuticals | 23 February 1988 |
| 1 kit in 1 carton * 10 mL in 1 bottle * 10 mL in 1 vial, glass | 0944-3944-02 | Takeda Pharmaceuticals | 23 February 1988 |
| 1 kit in 1 carton * 10 mL in 1 bottle * 10 mL in 1 vial, glass | 0944-3946-02 | Takeda Pharmaceuticals | 23 February 1988 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Antihemophilic factor human is a prescription medicine indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. It is available as kits. MedsAcross supplies Antihemophilic factor human for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Antihemophilic factor humanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- HEMOFIL M prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Hemofil M kit for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.